EP0974359A3 - FSH und FSH-Varianten enthaltende Arzneimittel, Erzeugnisse und Verfahren - Google Patents

FSH und FSH-Varianten enthaltende Arzneimittel, Erzeugnisse und Verfahren Download PDF

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Publication number
EP0974359A3
EP0974359A3 EP99305664A EP99305664A EP0974359A3 EP 0974359 A3 EP0974359 A3 EP 0974359A3 EP 99305664 A EP99305664 A EP 99305664A EP 99305664 A EP99305664 A EP 99305664A EP 0974359 A3 EP0974359 A3 EP 0974359A3
Authority
EP
European Patent Office
Prior art keywords
fsh
products
formulations
nucleic acids
methods
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP99305664A
Other languages
English (en)
French (fr)
Other versions
EP0974359B2 (de
EP0974359B1 (de
EP0974359A2 (de
Inventor
James Arthur Hoffmann
Jirong Lu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ares Trading SA
Original Assignee
Eli Lilly and Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=27536687&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP0974359(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Eli Lilly and Co filed Critical Eli Lilly and Co
Priority to SI9930156T priority Critical patent/SI0974359T1/xx
Priority to EP01130213A priority patent/EP1188444B1/de
Publication of EP0974359A2 publication Critical patent/EP0974359A2/de
Publication of EP0974359A3 publication Critical patent/EP0974359A3/de
Application granted granted Critical
Publication of EP0974359B1 publication Critical patent/EP0974359B1/de
Publication of EP0974359B2 publication Critical patent/EP0974359B2/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/59—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g.hCG [human chorionic gonadotropin]; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Endocrinology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Reproductive Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Otolaryngology (AREA)
  • Genetics & Genomics (AREA)
  • Pulmonology (AREA)
  • Dispersion Chemistry (AREA)
  • Pregnancy & Childbirth (AREA)
  • Gynecology & Obstetrics (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP99305664A 1998-07-23 1999-07-16 Benzylalkohol enthaltene FSH und FSH-Varianten Formulierungen Expired - Lifetime EP0974359B2 (de)

Priority Applications (2)

Application Number Priority Date Filing Date Title
SI9930156T SI0974359T1 (en) 1998-07-23 1999-07-16 FSH and FSH variant formulations comprising benzyl alcohol as a preservative
EP01130213A EP1188444B1 (de) 1998-07-23 1999-07-16 Stabile FSH und FSH Varianten enthaltende Arzneimitteln

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
US9390698P 1998-07-23 1998-07-23
US93906P 1998-07-23
US9461198P 1998-07-30 1998-07-30
US94611P 1998-07-30
US9476798P 1998-07-31 1998-07-31
US94767P 1998-07-31
US9871198P 1998-09-01 1998-09-01
US98711P 1998-09-01
US10069698P 1998-09-17 1998-09-17
US100696P 1998-09-17

Related Child Applications (1)

Application Number Title Priority Date Filing Date
EP01130213A Division EP1188444B1 (de) 1998-07-23 1999-07-16 Stabile FSH und FSH Varianten enthaltende Arzneimitteln

Publications (4)

Publication Number Publication Date
EP0974359A2 EP0974359A2 (de) 2000-01-26
EP0974359A3 true EP0974359A3 (de) 2001-02-07
EP0974359B1 EP0974359B1 (de) 2002-12-04
EP0974359B2 EP0974359B2 (de) 2009-04-22

Family

ID=27536687

Family Applications (2)

Application Number Title Priority Date Filing Date
EP01130213A Revoked EP1188444B1 (de) 1998-07-23 1999-07-16 Stabile FSH und FSH Varianten enthaltende Arzneimitteln
EP99305664A Expired - Lifetime EP0974359B2 (de) 1998-07-23 1999-07-16 Benzylalkohol enthaltene FSH und FSH-Varianten Formulierungen

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP01130213A Revoked EP1188444B1 (de) 1998-07-23 1999-07-16 Stabile FSH und FSH Varianten enthaltende Arzneimitteln

Country Status (24)

Country Link
EP (2) EP1188444B1 (de)
JP (1) JP4719357B2 (de)
KR (1) KR20010083126A (de)
CN (1) CN1309567A (de)
AR (1) AR020618A1 (de)
AT (2) ATE228850T1 (de)
AU (1) AU776823B2 (de)
BR (1) BR9912243A (de)
CA (1) CA2335340C (de)
CO (1) CO5090905A1 (de)
DE (2) DE69904262T3 (de)
DK (1) DK0974359T4 (de)
ES (2) ES2250290T3 (de)
HK (1) HK1026615A1 (de)
ID (1) ID28747A (de)
IL (1) IL140984A0 (de)
MY (1) MY135913A (de)
NO (1) NO20010326L (de)
NZ (1) NZ508874A (de)
PE (1) PE20000939A1 (de)
PL (1) PL346127A1 (de)
PT (1) PT974359E (de)
SI (1) SI0974359T1 (de)
WO (1) WO2000004913A1 (de)

Families Citing this family (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6414123B1 (en) 1997-10-21 2002-07-02 Vitro Diagnostics, Inc. Method for purifying FSH
US20030166525A1 (en) 1998-07-23 2003-09-04 Hoffmann James Arthur FSH Formulation
JP2002541213A (ja) 1999-04-13 2002-12-03 インヘール セラピューティック システムズ， インコーポレイテッド 不妊症の処置のための乾燥粉末処方物の肺投与
TWI318100B (en) 2001-03-01 2009-12-11 Lonza Ag Preservative blends containing quaternary ammonium compounds
DK1610822T4 (en) 2003-04-02 2019-01-14 Ares Trading Sa Liquid pharmaceutical FSH and LH formulations together with a nonionic surfactant
CA2526099C (en) 2003-06-20 2013-02-05 Ares Trading Sa Freeze-dried fsh / lh formulations
KR101105871B1 (ko) * 2005-09-27 2012-01-16 주식회사 엘지생명과학 인 난포자극호르몬의 안정한 용액 제형
EP2134165B1 (de) * 2007-02-08 2011-10-12 AspenBio Pharma, Inc. Zusammensetzungen und verfahren bezüglich der expression und biologischen aktivität von follikelstimulierendem hormon aus dem rind
JP5570980B2 (ja) 2007-06-28 2014-08-13 ラティオファーム ゲーエムベーハー Ｆｓｈ生産細胞クローン
JP5551601B2 (ja) * 2007-11-01 2014-07-16 メルク セローノ ソシエテ アノニム Ｌｈ液体調製物
ME01337B (me) 2008-02-08 2013-12-20 Biogenerix Ag Tečni preparat fsh
CN102309745B (zh) * 2008-09-17 2013-05-08 上海天伟生物制药有限公司 一种卵泡刺激素冻干针剂
PL2445552T3 (pl) 2009-06-24 2016-03-31 Tecpharma Licensing Ag Przyrząd aplikacyjny z funkcją reaktywacji
EP2325194A1 (de) 2009-11-24 2011-05-25 Glycotope GmbH Verfahren zur Reinigung von Glykoproteinen
WO2011076281A1 (de) 2009-12-23 2011-06-30 Tecpharma Licensing Ag Entfernen einer nadelschutzkappe von einer nadel
EP2515973B1 (de) 2009-12-23 2018-02-21 Tecpharma Licensing AG Injektionsvorrichtung mit einer nadelschutzhülse
WO2011098129A1 (en) 2010-02-11 2011-08-18 Finox Ag Injection training dummy
WO2011099036A2 (en) * 2010-02-12 2011-08-18 Intas Biopharmaceuticals Limited Liquid formulation of follicle stimulating hormone
EP2417982A1 (de) * 2010-07-30 2012-02-15 Ferring B.V. Stabilisierung von Gonadotropinen
KR20140018970A (ko) * 2011-04-22 2014-02-13 샹하이 테크웰 바이오파마슈티컬 컴퍼니, 리미티드 저수준 잔류용매를 함유한 당단백질 조성물 및 그 제조방법과 용도
JP5750471B2 (ja) * 2013-05-22 2015-07-22 Ｊｃｒファーマ株式会社 組換え体ヒトｆｓｈの製造方法
CN103539860B (zh) * 2013-11-01 2014-12-03 广州优联康医药科技有限公司 一种长效重组人促卵泡激素融合蛋白
CN103539861B (zh) * 2013-11-01 2015-02-18 广州联康生物科技有限公司 长效重组人促卵泡激素融合蛋白
CN103554269B (zh) * 2013-11-01 2015-02-11 广州联康生物科技有限公司 重组猪促卵泡激素融合蛋白
IN2013MU03559A (de) * 2013-11-12 2015-07-24 Cadila Healthcare Ltd
CN113198005B (zh) * 2015-09-17 2024-09-06 广州汉腾生物科技有限公司 具有提高的稳定性的哺乳动物促卵泡激素组合物
GB201603280D0 (en) * 2016-02-24 2016-04-13 Ferring Bv Stable liquid gonadotropin formulation

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0448146A1 (de) * 1990-03-20 1991-09-25 Akzo Nobel N.V. Stabilisierte Gonadotropin enthaltende Zubereitungen
US5162306A (en) * 1987-01-23 1992-11-10 Donaldson Lloyd E Composition and method for producing superovulation in mammals
WO1993011788A1 (en) * 1991-12-18 1993-06-24 Applied Research Systems Ars Holding N.V. Gonadotropin containing pharmaceutical compositions with sucrose stabilizer
EP0853945A1 (de) * 1997-01-15 1998-07-22 Akzo Nobel N.V. Flüssige gonadotropinhaltige Arzneimittel

Family Cites Families (14)

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GB839300A (en) * 1957-09-05 1960-06-29 Organon Labor Ltd Adrenocorticotropic hormone preparations and process for making same
US4659696A (en) † 1982-04-30 1987-04-21 Takeda Chemical Industries, Ltd. Pharmaceutical composition and its nasal or vaginal use
IT1206302B (it) * 1987-06-26 1989-04-14 Serono Cesare Ist Ricerca Ormone follicolo-stimolante urinario
FR2623715B1 (fr) * 1987-11-26 1990-12-21 Lafon Labor Structures peptidiques, immunogenes les contenant et leurs applications au controle de la fertilite
US5733572A (en) * 1989-12-22 1998-03-31 Imarx Pharmaceutical Corp. Gas and gaseous precursor filled microspheres as topical and subcutaneous delivery vehicles
NZ255158A (en) * 1992-07-31 1997-09-22 Genentech Inc Human growth hormone; stable pharmaceutically acceptable aqueous formulation and means for preparing and storing it
US5661125A (en) * 1992-08-06 1997-08-26 Amgen, Inc. Stable and preserved erythropoietin compositions
US5594091A (en) † 1994-02-21 1997-01-14 Takeda Chemical Industries, Ltd. Matrix for sustained-release preparation
JP2758154B2 (ja) * 1995-04-06 1998-05-28 エフ・ホフマン−ラ ロシユ アーゲー インターフェロンを含む液体製剤
CA2234231C (en) * 1995-11-07 2009-04-14 Genentech, Inc. Stabilizing formulation for ngf
GB2317010A (en) * 1996-09-04 1998-03-11 Eev Ltd Gas sensor detecting only non-reflected light
US6287587B2 (en) † 1997-07-15 2001-09-11 Takeda Chemical Industries, Ltd. Process for producing sustained-release preparation by in-water drying
MY120063A (en) * 1997-12-09 2005-08-30 Lilly Co Eli Stabilized teriparatide solutions
JP2000151148A (ja) * 1998-11-13 2000-05-30 Mitsumi Electric Co Ltd 携帯用電子機器のコード接続構造

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5162306A (en) * 1987-01-23 1992-11-10 Donaldson Lloyd E Composition and method for producing superovulation in mammals
EP0448146A1 (de) * 1990-03-20 1991-09-25 Akzo Nobel N.V. Stabilisierte Gonadotropin enthaltende Zubereitungen
WO1993011788A1 (en) * 1991-12-18 1993-06-24 Applied Research Systems Ars Holding N.V. Gonadotropin containing pharmaceutical compositions with sucrose stabilizer
EP0853945A1 (de) * 1997-01-15 1998-07-22 Akzo Nobel N.V. Flüssige gonadotropinhaltige Arzneimittel

Also Published As

Publication number Publication date
AU776823B2 (en) 2004-09-23
ID28747A (id) 2001-06-28
DE69904262D1 (de) 2003-01-16
JP4719357B2 (ja) 2011-07-06
AR020618A1 (es) 2002-05-22
SI0974359T1 (en) 2003-04-30
WO2000004913A1 (en) 2000-02-03
PL346127A1 (en) 2002-01-28
EP1188444B1 (de) 2005-11-09
ATE308990T1 (de) 2005-11-15
HK1026615A1 (en) 2000-12-22
EP0974359B2 (de) 2009-04-22
AU4998099A (en) 2000-02-14
DE69928296T2 (de) 2006-07-27
ES2183486T3 (es) 2003-03-16
NO20010326D0 (no) 2001-01-19
DK0974359T3 (da) 2003-03-03
CA2335340C (en) 2013-03-05
DE69904262T2 (de) 2003-07-24
BR9912243A (pt) 2001-10-16
NO20010326L (no) 2001-03-20
PE20000939A1 (es) 2000-09-20
DE69928296D1 (de) 2005-12-15
KR20010083126A (ko) 2001-08-31
CO5090905A1 (es) 2001-10-30
PT974359E (pt) 2003-02-28
DE69904262T3 (de) 2009-08-13
CN1309567A (zh) 2001-08-22
NZ508874A (en) 2004-03-26
DK0974359T4 (da) 2009-06-29
IL140984A0 (en) 2002-02-10
CA2335340A1 (en) 2000-02-03
ES2250290T3 (es) 2006-04-16
EP0974359B1 (de) 2002-12-04
MY135913A (en) 2008-07-31
EP0974359A2 (de) 2000-01-26
JP2002521342A (ja) 2002-07-16
ATE228850T1 (de) 2002-12-15
EP1188444A1 (de) 2002-03-20

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